Compliance Coordinator - ICTS Regulatory Core
The Compliance Coordinator at the Confidential Client supports regulatory activities for clinical trials and research studies, ensuring adherence to local, federal, and sponsor guidelines. This role manages regulatory documentation, coordinates IRB submissions, assists with audits, and collaborates with multidisciplinary teams to foster research innovation. The position offers a hybrid work arrangement within Iowa and requires strong organizational and communication skills along with knowledge of clinical research regulations.
About Careertakes
👉 Important disclosure: Careertakes is a third-party recruiting platform supporting this hiring process. If selected, you will be employed directly by our client, Scientific & QA.
Applicants for this role may also receive access to additional matched opportunities through the Careertakes platform.
Position Overview
The Confidential Client is seeking a Regulatory Compliance Coordinator I to support the Institute for Clinical and Translational Science (ICTS). In this full-time role you will coordinate and manage clinical trial and research-study regulatory activities, support IRB and committee submissions, help with audits and monitor visits, maintain regulatory files (including conversion to electronic formats), and ensure compliance with local, federal, and sponsor-specific requirements.
What You’ll Do
- Monitor compliance with local, federal, and sponsor regulatory guidelines and maintain regulatory files and binders; assist in converting paper records to secure electronic records as directed.
- Support sponsor on-site audits and monitor visits; resolve basic monitoring and auditing issues and perform basic evaluation of deviations.
- Prepare and submit Human Subjects Review forms and other committee applications (CRU, Pharmacy & Therapeutics, Medical Radiation Protection, Protocol Review & Monitoring, etc.) under the direction of senior regulatory staff.
- Open, maintain, and close clinical trials; after onboarding, manage multiple new study start-ups and modifications concurrently (typical expectation: maintain 2–3 new studies and modify several ongoing studies).
- Prepare documents for annual reviews, modifications, adverse events, safety reports and other reportable events; draft regulatory correspondence to IRBs and sponsors as directed.
- Collaborate with clinicians, investigators, data managers, nursing, pharmacy and other stakeholders to ensure coordinated study operations.
- Assist senior staff with regulatory-related data analysis and prepare meeting materials and study updates.
- Develop basic study and recruitment materials and support obtaining IRB approval for those materials.
- Prepare and deliver basic training and educational resources that promote adherence to internal and external standards.
Qualifications
- Bachelor’s degree in Business Administration, Accounting, or equivalent combination of education and experience.
- Minimum 1 year experience preparing institutional review board (IRB) submissions and 1 year processing research regulatory documents.
- Knowledge of regulatory affairs and Good Clinical Practice (GCP) in clinical research.
- Proficiency with computer applications including spreadsheets and databases.
- Strong written, verbal, and interpersonal communication skills.
- Strong organizational, time-management, and attention-to-detail skills; ability to coordinate multiple projects independently.
- Demonstrated ability to handle sensitive and confidential information appropriately.
Desirable Qualifications
- Experience with OnCore, eREG, REDCap, Epic and I-CART.
- CCRP certification.
- Previous experience working with university systems, policies, procedures and administrative processes.
Compensation & Benefits
- Rate: $100 per hour.
- Employment type: Full-time (100%).
- Benefits highlights include paid vacation, sick leave; health, dental, life and disability insurance options; and employer contributions to retirement plans.
Work Location & Schedule
- Hybrid within Iowa: this position supports a combination of on-campus and remote work. Remote work must be performed from a location within the state of Iowa and must comply with the client’s remote work program and policies.
- Successful candidates will be required to self-disclose conviction history and will be subject to criminal background checks and credential/education verification. Professional references may be requested.
- This position is not eligible for University or employer sponsorship for employment authorization.
Equal Opportunity & Hiring Transparency
Careertakes and our client are Equal Opportunity Employers committed to building a diverse and inclusive workforce. We prohibit discrimination or harassment of any kind. To support a fair and efficient hiring process, AI tools may be used to assist with application review or resume screening. These tools do not replace human decision-making. Final hiring decisions are made by people.
If you have questions about how your data is used, please contact us directly.
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